Prospective Randomized Phase IV Open Label Comparative Study Of Tranexamic Acid Plus Standard Of Care Vs Standard Of Care For The Reduction Of Blood Loss In Patients Undergoing Major Abdominal Surgery
18 Years
N/A
Both
Biliary Tract Surgical Procedures, Pancreaticoduodenectomy, Esophagectomy, Colectomy, Gastrectomy
Trial Information
Prospective Randomized Phase IV Open Label Comparative Study Of Tranexamic Acid Plus Standard Of Care Vs Standard Of Care For The Reduction Of Blood Loss In Patients Undergoing Major Abdominal Surgery
Inclusion Criteria:
- Patient undergoing major abdominal surgery (Biliary strictures,
Pancreatico-duodenectomy, Esophagectomy, Total proctocolectomy, Hemicolectomy,
Gastrectomy, Other major abdominal surgeries with similar expected blood loss)
Exclusion Criteria:
- Patients with a platelet count less than 100, 000/mm3 or history of thrombocytopenia.
- Patients with known coagulopathy.
- Patients with anemia (hemoglobin levels less than 8 mg/dl)
- Patients with documented DVT or PE at screening or in past three months.
- Patients with any associated major illness (e.g., severe cardiac or respiratory
disease).
- Anticoagulants (other than LMWH or heparin in prophylactic doses to prevent deep vein
thrombosis), direct thrombin inhibitors or thrombolytic therapy administered or
completed within last week
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Post-operative Blood Loss
Outcome Description:
Post-operative blood loss was defined as the sum of the drainage volumes measured over post-operative days 1, 2, and at drain removal. It was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed.
Outcome Time Frame:
Post-operation, Day 1, Day 2 up to drain removal
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
India: Institutional Review Board
Study ID:
B1461001
NCT ID:
NCT00827931
Start Date:
September 2009
Completion Date:
May 2011
Related Keywords:
- Biliary Tract Surgical Procedures
- Pancreaticoduodenectomy
- Esophagectomy
- Colectomy
- Gastrectomy
- tranexamic acid
- major abdominal surgery
- blood loss
- Hemorrhage
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